A Mass Balance Study of [14C]ABSK011
ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAbbisko Therapeutics Co, Ltd
About this trial
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of \[14C\] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.
Eligibility criteria
Qualifiers
Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;
Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)/height (m) ²;
Participants must have regular defecation in the past three months;
Disqualifiers
Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
Trial design
Treatments tested in this trial
- [14C]ABSK011
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov